What to Expect Now That Larger Farms Must Comply with the FSMA Produce Safety Rule

A Conversation with Samir Assar

The first major compliance date for the Produce Safety Rule under the FDA Food Safety Modernization Act (FSMA) arrived on January 26, 2018, when larger farms must comply with the rule that, for the first time, establishes science-based standards for the safe growing, harvesting, packing and holding of fruits and vegetables.

It’s important to note that routine inspections under the Produce Safety Rule will not begin until the spring of 2019 to give both farmers and state regulators more guidance, training, technical assistance, and planning and ensure that they have the tools they need.

Sprout growers have already had to meet the requirements specific to them. But for all other farming operations, January 26, 2018 was the first of the major compliance dates that are staggered based on farm size. Small and very small farming operations must comply with applicable standards in 2019 and 2020, respectively.

So what do farmers need to know about this January compliance date? Samir Assar, Ph.D., the director of FDA’s Division of Produce Safety in the Center for Food Safety and Applied Nutrition, explains what will happen in this next stage of implementing the FSMA rule entitled “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.”

Q: What happened on January 26?

Larger farms, those that have sold an average of more than $500,000 in produce during each of the past three years, must comply with the requirements that apply to them. These requirements include standards for worker training, health and hygiene, domesticated and wild animals; and other standards designed to ensure that that equipment, tools and buildings are properly cleaned and maintained to prevent produce contamination. While the establishment of a standard for the interval between application and harvest for raw manure used as fertilizer has been deferred, there are microbial limits on the presence of certain pathogens in stabilized compost, which has been treated using scientifically valid processes that meet certain standards under the rule.

Q: What happens next in terms of FDA enforcement of these requirements?

Our focus with this January 26 compliance date will still be on educating farms of all sizes. FDA’s Commissioner, Dr. Scott Gottlieb, announced last September that routine inspections under the Produce Safety Rule, except for inspections of sprout growers, will not begin until 2019. We want to ensure that farmers have the training and information they need. We also want to ensure that states have the time they need to establish strong produce safety programs since states, for the most part, will be doing these inspections.

Delaying routine inspections under the Produce Safety Rule will give the larger farms some flexibility to ensure that their system is operating correctly as guidance from FDA and other resources are put in place.

We want to support widespread compliance by making sure that everyone involved has the information needed to best prepare them for the successful implementation of this rule. One of the efforts that will help support farmers is the On-Farm Readiness Review, a voluntary farm visit by a team of state officials, cooperative extension agents and FDA produce experts to help them assess their “readiness” to meet the new requirements.

Q: Some key requirements in the final rule have been proposed to be or have been put on hold. What does this mean to farmers?

The most significant area currently proposed to be put on hold is the one affecting the microbial standards and testing for agricultural water. We have gotten a lot of feedback from farmers and the produce industry that the numerical criteria for microbial water quality in the final rule are too complex to understand and implement. Last September, we issued a proposed rule to extend the compliance dates for the agricultural water requirements for produce other than sprouts. If finalized, the earliest compliance date for most agricultural water provisions would be January 2022 for the largest farms. This would give us time to work with stakeholders to develop the most practical and effective approach. The Federal Food, Drug, and Cosmetic Act has provisions to protect consumers from foods that could harm them, and those requirements of food producers are still in place. But speaking specifically about the agricultural water requirements in the Produce Safety Rule, we do not intend to enforce them while the rulemaking to extend the compliance dates is underway. We are continuing our dialogue with stakeholders, and as part of that process we will be participating in a February 27-28 summit on agricultural water hosted by the Produce Safety Alliance.

We are also still working on standards related to minimizing the risk of contamination from the use of raw manure as fertilizer. We’re conducting a risk assessment, conducting extensive research, and working with stakeholders. This is a work in progress. There was recently a third soil summit, and we’ve been following through on what we learned in the first two, developing a model for the collection of data and generally trying to turn words into actions.

I also want to note that there will be regional meetings to ensure that everyone’s voice is heard on both water and certain biological soil amendments.

Q: Enforcement discretion has been announced for other provisions. What does this mean for farmers?

The areas of enforcement discretion that have the biggest impact on farmers and some other operations are related to how FDA defines a farm. There are certain activities, such as packing or holding raw produce, that are considered subject to the Produce Safety Rule if conducted on a farm. But if the same activities are conducted off the farm, they are subject instead to the preventive controls rules. Stakeholders have argued that it makes no sense to apply different standards to the same activities, and that those related to farming should just be under the produce rule.

Specifically, one part of the enforcement discretion covers the preventive controls requirements for operations that currently do not fit within the farm definition because they conduct certain activities not included within the definition (e.g., coloring raw agricultural commodities) or do not meet the ownership requirement to be a secondary activities farm (e.g., some packinghouses).

The enforcement discretion is intended to give FDA time to resolve such issues.

Q: Why have sprout growers already had to comply with the Produce Safety Rule?

Sprouts, which have been frequently associated with outbreaks of foodborne illness, are especially vulnerable to dangerous bacteria because of the warm, moist and nutrient-rich conditions needed to grow them. The rule requires specific measures to prevent contamination, including separate water requirements that were not included in the proposal to extend the compliance date for other agricultural water requirements. The larger sprout operations had to comply with the Produce Safety Rule in January 2017, and small businesses had to meet the January 26, 2018, deadline.

Q: Would you say more about the On-Farm Readiness Reviews (OFRR), which have been mentioned as a resource for farmers this year. What are these, and when can farmers sign up for them?

The National Association of State Departments of Agriculture (NASDA) has been working closely with FDA and our state partners to develop this voluntary program for farmers. This is an educational opportunity to help farmers assess how well they’re prepared to meet the requirements of the Produce Safety Rule. If a farmer chooses to participate, a team that includes state and FDA regulators and educators would visit the farm to offer insights, advice and technical assistance, and to answer any questions that the farmer may have about his/her specific operation. This program has been piloted in six states and will begin rolling out nationally this spring. As part of this program, NASDA and FDA have developed tools for farmers to conduct their own self-assessment. When the program rolls out, more information will be coming from NASDA, FDA and/or the participating states.

Q: What happens if the visiting OFRR team sees a potentially hazardous condition during the review?

If state and federal regulators see something that could present a risk to public health, but the farm makes immediate corrections to the reviewers’ satisfaction, and no affected produce has or will enter commerce, then reviewers would not document the issue or alert FDA.

But if such conditions have been observed and produce has already entered commerce, then the observation needs to be documented and/or reported to FDA, as a recall or other appropriate action may be triggered.

The PSN is a network of specially trained FDA staff located throughout the country to support both farmers and the state regulators who will be working with them. The PSN also works with other industry stakeholders, such as cooperative extension agents and educators, to develop and share information helpful to the farming community. This team will provide technical assistance, outreach, help with outbreak investigations and, where needed, conduct foreign and domestic inspections.

PSN members are actively working with state produce program staff to learn more about the challenges faced in their regions. One way they’re doing this is by interacting directly with farmers. In 2017, PSN and state staff participated in educational visits to 117 U.S. farms to listen to the challenges faced by farmers, learn about unique growing conditions and practices, and address questions and concerns about the Produce Safety Rule.

The PSN page on fda.gov has information about what the network has to offer and how to contact its members.

Q: What role will state and tribal governments and cooperative extension agents have in helping to implement the Produce Safety Rule?

Most farmers will be interacting with state and tribal officials as they work to meet their FSMA requirements. Successful implementation depends on the strength of partnerships between FDA and the states, both to deliver education and technical assistance, and to provide on-going compliance support and oversight. State agriculture officials have strong relationships with and knowledge of local farming communities and practices.

In 2017, FDA awarded more than $30 million to fund the State Produce Implementation Cooperative Agreement Program (CAP) to support 43 states in their development of produce safety programs. This builds on the nearly $22 million in cooperative agreements that FDA awarded in 2016 to 42 states to develop produce programs and provide training and technical assistance. Most states chose the option that includes funding for an inspection, compliance, and enforcement program, in addition to grower education, outreach, training, and technical assistance.

For the states that have not yet applied for funding through CAP, there’s still an opportunity to participate in the program. When routine inspections under the Produce Safety Rule begin in the spring of 2019, FDA will conduct inspections in states with which we do not have a cooperative agreement.

Cooperative extension agents affiliated with colleges and universities across the country have long had a valuable role in providing training and technical assistance to the farmers in their regions. We have been working with our training and education partners, including the Produce Safety Alliance, to ensure that cooperative extension agents have all the information they need to best support the farmers who must meet the new standards.

Q: What about third-party audits? What role will they have in implementation?

The Produce Safety Rule does not require audits, but farmers may be dealing with private audits required by buyers. However, farmers should know that meeting the requirements of private audits does not necessarily mean that they are compliant with the FSMA standards. That said, some private certification scheme owners have been working to update their requirements to be consistent with FSMA. It will be to everyone’s benefit that any audits considered necessary by buyers meet our regulatory standards.

Q: What progress has been made in providing training for both farmers and regulators?

A lot of work to provide FSMA training has already been done through the Produce Safety Alliance and other programs. Through the PSA training alone, thousands of farmers have been trained.

FDA and USDA have funded a network of public and private training partners in state, federal, tribal and international governments; industry; and academia. The FSMA Collaborative Training Forum is the lynchpin for this group, providing a space for information sharing, alignment and collaboration. We just posted a Forum web page with links to all the training providers.

The training of state and federal regulators is also a top priority in 2018. We have been working with NASDA and our state partners on these plans and have six regulator training courses planned for 2018. We are committed to offering more training courses as needed to ensure that state and FDA regulators are appropriately trained.

Q: When will the guidance for the Produce Safety Rule be coming out?

We expect to publish a draft guidance early this year. Currently under review, the produce guidance will provide our thinking on ways to meet the requirements in the Produce Safety Rule. It has taken a while to develop the guidance because it must be broad enough to meet the needs of a domestic and international audience, but specific enough to meet local and regional needs. Each region of the country has unique challenges and growing conditions. So developing a document that can bridge those differences has taken time. We’ve worked closely with our state partners to get this right.

We understand and agree that it will be important to develop additional tools to summarize, condense, and provide specific examples of certain situations once the guidance is issued. We will work with our state partners and industry to develop additional tools as needed.

Q: What is FDA doing to ensure that produce grown in other countries and imported for sale in the United States is held to the same safety standards?

FSMA requires that foreign food producers meet the same safety standards as domestic food producers. The Foreign Supplier Verification Programs (FSVP) rule makes importers of produce responsible for ensuring that their suppliers are producing food in a manner that meets the same level of public health protection as the Produce Safety Rule.

If importers want to participate in the Voluntary Qualified Importer Program (which launched on January 31, 2018) to provide expedited review and entry, they are required to provide a certification for their foreign supplier’s facility to show that it is meeting the applicable FDA safety standards. This certification must be provided under another program established by FSMA, FDA’s Accredited Third-Party Certification Program.

Also on the international front, the FDA has fostered the establishment of the Produce International Partnership for Education and Outreach between the Joint Institute for Food Safety and Nutrition (a partnership between FDA and the University of Maryland) and the Produce Safety Alliance. The partnership is charged with coordinating the dissemination of food safety training and outreach to the international farming community. This outreach is considerate of cultural, technological and language differences.

Through our foreign posts, FDA is reaching out to our foreign regulatory counterparts. For example, we receive a great deal of produce from Latin America, and our Latin America Office is actively engaged with our trading partners on outreach.

Q: What does the delay in inspections mean for foreign firms whose importers must comply with the Foreign Supplier Verification Programs (FSVP) rule?

Under the FSVP rule, importers of produce must verify, among other things, that their foreign suppliers use processes and procedures that offer the same level of public of public health protection as is provided by the Produce Safety Rule. However, because the FDA is not yet beginning routine inspections under the Produce Safety Rule, the agency will also not begin FSVP inspections for produce importers until next year. This way the start of the FSVP inspections for these importers will be aligned with the start of produce inspections. That said, even though we are not beginning routine inspections, importers of produce must still comply with the FSVP requirements in accordance with the applicable compliance dates.

Q: What is the best thing covered farms can be doing now?

As we discussed, larger farms faced the January 26, 2018, deadline. But all covered farms should be getting ready to comply. They should be making sure that their employees understand what will be required and why. They should be looking closely at their operations to assess whether they are meeting the requirements of the Produce Safety Rule. Start thinking: What training do we need? What may we have to adjust in our work processes to meet these standards?

Farms that meet the standards for a qualified exemption and associated modified requirements should be maintaining the records needed to establish that they are eligible. Farms are eligible if, on average during the previous three years, they grossed less than $500,000 annually in all food sales and sold the majority of their food directly to consumers, or restaurants or retail food establishments that are the same state or reservation as the farm, or not more than 275 miles away.

Q: What do you most want farmers and other stakeholders to know?

This is a marathon, not a sprint. We appreciate the input we’ve received from farmers and other stakeholders, and we look forward to continued dialogue. We’re addressing many of the concerns that have been raised, and will continue to do so. Our overriding goal is to work in partnership with farmers, the produce industry, regulatory partners and other stakeholders to have a system in place that systematically works to keep fruits and vegetables free of contamination. We’re all consumers. We all want that for ourselves and our families.